MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3; IMPLANTABLE LEAD

Model Number	4525
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited dislodgement.This lv lead was surgically abandoned.A new lead with a different model was successfully implanted.No additional adverse patient effects were reported.

• Brand Name: EASYTRAK 3
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22869311
• Report Number: 2124215-2025-58880
• Device Sequence Number: 12984065
• Product Code: NIK
• UDI-Device Identifier: 00802526353772
• UDI-Public: (01)00802526353772(17)060809
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/09/2006
• Device Model Number: 4525
• Device Catalogue Number: 4525
• Device Lot Number: 156795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 09/02/2004
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male